The user facility reported the vitrector was not cutting at speeds higher than 1500 cpm.The vitrectomy was discontinued due to continued excessive vitreous traction and no apparent cutting of vitreous.The posterior capsule was broken with vitreous prolapse.Post-op day 1, there were no visible retinal tears.Post-op day 2, the patient reported flashes of light in the right eye.No retinal tears were visible.Post-op 1 week, the patient reported increased flashes and floaters.Inferior and nasal retinal detachment diagnosed on (b)(6) 2019, the macula was still attached.Retinal reattachment surgery was performed on (b)(6) 2019.The macula was attached at the time of surgery and five retinal tears were noted.Additional intervention was pars plana vitrectomy, gas fill, endolaser, face down positioning for a week with limited physical activities.Post-op on (b)(6) 2019, the patient has spectacle corrected vision of 20/25.Retina exam showed attached retina (including the macula) and 48% gas fill remaining in eye.
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A review of the device history record found the system met specifications.The compressor module and fluidics module underwent additional screening when the system was manufactured based on a suspected issue with the cassette vacuum check at higher elevation locations.The associated non-conformance and corrective action are not contributors to the complaint.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No further investigation or corrective action is required.
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